- Plans, schedules, conducts and follows up primarily on GxP Audits of company Sites, but also as required by the business and sr. management; Material Suppliers, Contract Operations or Contract Service Providers to assure company and its business partners comply with applicable cGxP. Applies appropriate GxP standard based on location / where marketed and function.
- Depending on expertise may lead GMP (manufacturing), GCP (clinical), GDP (distribution), GLP (laboratory), or GPvP (Pharmacovigilance) audits to company standards and requirements, as well as US FDA, MHRA, EMA, TGA or other local regulatory authority standards.
- Leads or participates in assigned projects to establish or improve corporate audit and/or quality compliance governance processes to assure robust processes met stakeholder expectations.
- Plans, schedules, coordinates, leads or participates and follows up on assigned GxP audits of company Sites / functions, material suppliers (pharmaceutical or nutritional ingredients / materials) and / or contract Operations or Service Providers (manufacturers, packagers, laboratories, contract research organizations or related testing or study sites). This includes timely, life-cycle management of assigned audits by
- Developing and communicating appropriate scope, plan and agenda
- Effectively managing time / tasks to assure appropriate audit preparation, efficient execution of audit activities, and timely reporting and follow-up
- Skillfully analyzing audit data and correctly identifying departures from GxP
- Following up on audit observations and CAPA through closure and verification
- Leads or participates in assigned projects to establish or improve Corporate Quality Audit and/or Quality Compliance Governance processes to assure that processes are robust and meet key stakeholder requirements. May require the development and / or revision of Corporate Quality Compliance department Operating Procedures to assure compliance with cGxP and alignment with Global Policies and Standards.
- Maintain current knowledge of changes to regulatory landscape and continuously seeks growth and excellence through monitoring sources of information, attending industry / regulatory learning events and/or pursuing appropriate certifications.
- Provides cGxP consulting and/or develops and delivers learning and training to company sites and functions.
- Requires significant domestic and international travel (approximately 60%).
- Bachelor’s degree in a scientific discipline or closely aligned field. Advanced relevant qualification a benefit.
- Ten plus years of experience in GxP regulated industry, at least five of which is in GxP audit / compliance environment.
- Must possess thorough understanding of, and ability to interpret, GxP regulatory requirements relative to one or more country/region that company operates or markets product.
- Subject matter expertise in one or more area of GxP (e.g. GMP, GCP, GLP, GPvP) relative to medical and/or nutritional product development, manufacturing and/or supply chain.
- Strong analytical and interpersonal skills, commanding oral and written communication ability.
- Self-directed and able to work effectively and independently across multiple global cultures in a matrix environment.
- Ability to influence management, peers and other colleagues without direct reporting lines.
- Quality Auditor designation/certification preferred.